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HODGE SUPPLY CHAIN (HK) LIMITED

⚠️ Moderate Risk

FEI: 3028257579 • Kwai Chung • HONG KONG

FEI

FEI Number

3028257579

📍

Location

Kwai Chung

🇭🇰

Country

HONG KONG
🏢

Address

Rm 2110, Block A Regent Centre; 63 Wo Yip Hop Road, Kwai Chung,Nt, Kwai Chung, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

38.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
12/26/2023
Latest Refusal
12/26/2023
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
58.6×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/26/2023
86LOHSYSTEM, IDENTIFICATION, CONTACT LENS
473LABELING
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HODGE SUPPLY CHAIN (HK) LIMITED's FDA import refusal history?

HODGE SUPPLY CHAIN (HK) LIMITED (FEI: 3028257579) has 1 FDA import refusal record(s) in our database, spanning from 12/26/2023 to 12/26/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HODGE SUPPLY CHAIN (HK) LIMITED's FEI number is 3028257579.

What types of violations has HODGE SUPPLY CHAIN (HK) LIMITED received?

HODGE SUPPLY CHAIN (HK) LIMITED has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about HODGE SUPPLY CHAIN (HK) LIMITED come from?

All FDA import refusal data for HODGE SUPPLY CHAIN (HK) LIMITED is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.